Adzynma (rADAMTS13)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- rADAMTS13
- Company
- Takeda Manufacturing Austria AG
- Status
- Authorised
- Therapeutic area
- Purpura, Thrombotic Thrombocytopenic
- CHMP opinion
- Thu 30 May 2024
- EU approval
- Thu 01 Aug 2024
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/006198
- ATC
- B01AD13
- Official record
- www.ema.europa.eu
Indication
Treatment of congenital thrombotic thrombocytopenic purpura (cTTP) due to ADAMTS13 deficiency
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.